Protective role of alpha-lipoic acid in chemotherapy-induced mucositis for colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2/3 interventional study evaluating alpha-lipoic acid 600 mg twice daily versus placebo in adults with newly diagnosed colorectal cancer who are planned to receive FOLFOX-6 as part of adjuvant, neoadjuvant, or palliative therapy. The study aims to see if ALA can lessen the incidence or severity of chemotherapy-induced oral mucositis by reducing oxidative stress and inflammation. Participants are randomized to ALA or placebo and followed for mucositis outcomes, safety, and treatment tolerance. Key eligibility includes adequate organ function and absence of prior ALA use or other antioxidants; exclusions include other primary cancers and inability to tolerate oral intake. The trial is led by Ain Shams University with sites at Nasser Institute for Research and Treatment in Cairo, Egypt.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \>18 years.
2. Newly diagnosed chemotherapy naive CRC patients
3. Planned to receive FOLFOX-6 protocol as adjuvant, neoadjuvant or palliative therapy.
4. Adequate liver function (liver transaminases level \< 3 times upper normal limits and total bilirubin \< 1.5 times upper normal limits).
5. Adequate kidney function (estimated glomerular filtration rate \>60 ml/min).
6. Adequate bone marrow function (WBCs count \> 3000 cells/mm3, ANC count \>1500 cells/mm3 and platelets count \> 100,000 cells/mm3).

Exclusion Criteria:

1. Presence of other primary cancers.
2. Treatment with ALA for any other indication.
3. Allergy to ALA.
4. Pregnant or lactating women.
5. Patients with previous mucositis for any reason.
6. Patients who cannot tolerate oral intake.
7. Patients receiving other dietary antioxidant supplements.

Where it's running

• Nasser Institute for Research and Treatment.
  Cairo, Egypt Recruiting

Study contacts

• Study coordinator: Ghada Ramadan Youssef
• Email: ghada.ms2425015@pharma.asu.edu.eg
• Phone: +20 01097001838

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Knife-assisted full-thickness resection for rectal lesions in a multicenter setting

  A multicenter study tests knife-assisted full-thickness resection (kFTR) to remove rectal lesions in adults and see how well it works and how safe it is.

  Recruiting University Hospital, Ghent · Ghent · NCT07923682

• Personalized 3D Bioprinted Colorectal Cancer Microenvironment Model

  This study tests patient-derived, 3D-bioprinted cancer models that include tumor, fibroblast, and immune cells to see if they can better predict how colorectal cancer will respond to treatment.

  Recruiting Peking Union Medical College Hospital · Ningbo, Zhejiang · NCT07919418

• Integrated genomic and clinical database for cancer biomarker discovery

  Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.

  Recruiting Samsung Medical Center · Seoul, Gang-Nam · NCT07911267

• Prehabilitation with Resistance, Aerobic, or Both Before Colorectal Surgery

  Four pre-surgery exercise options (resistance, aerobic, both, or none) will be tested to see which best reduces complications after colorectal cancer surgery.

  Recruiting Semmelweis University · Budapest · NCT07896174

• Liver transplantation for colorectal cancer with liver metastases

  This study follows adults with stage IV colorectal cancer whose disease is limited to the liver and who are getting a liver transplant as part of their cancer care to see how they fare over time.

  Recruiting Pontificia Universidad Catolica de Chile · Santiago, Santiago Metropolitan · NCT07884110

• LTZ-232: a first-in-human test in advanced colorectal and other solid tumors

  A first-in-human study tests LTZ-232, a new therapy for adults with unresectable or metastatic colorectal cancer and other solid tumors that have not responded to standard treatments.

  Recruiting Phase 1 LTZ Therapeutics, Inc. · Scottsdale, Arizona · NCT07878988

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.